Trigeminal NeuralgiaNCT04579692
MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
A study testing ExAblate Transcranial treatment in people with Trigeminal Neuralgia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- ExAblate Transcranial treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of Classical or Idiopathic TN refractory to medical therapy
- Age greater than 21 and less than 75 years
- Subjects who are able and willing to give consent and able to attend all study visits
- Documented chronic, severe pain for more than 6 months duration
- Failure to respond to the usual therapeutic regimen considered to be standard of care for Trigeminal Neuralgia. The patient should have failed a trial of at least two classes of therapeutic agents, including an anticonvulsant agent
- Patient with Trigeminal Neuralagia who has either failed a prior surgical approach considered to be standard of care for TN (Micro-vascular decompression, radiofrequency, stereotactic, Radiosurgery or glycerol) or is not considered to be an acceptable candidate for one of those alternative options (due to anesthesia risk, medical comorbidities or Patient refusal despite counseling).
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- Central lateral thalamotomy is feasible based on evaluation of imaging studies
- Patient able to communicate sensations during the Exablate TcMRgFUS treatment
- Two members of the medical team have agreed upon inclusion and exclusion criteria.
Who cannot join
- Patient with contra-indications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
- Severe psychiatric disorder such as uncontrolled depression, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
- Life expectancy less than 12 months
- Anticoagulant or antiplatelet medications as well as underlying coagulopathy
- Prior or currently implanted thalamic DBS
- Pregnant ladies or women of childbearing age who are sexually active and not using contraception
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- Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
- Presence of intracranial mass or an acute intracranial abnormality
- Subjects with unstable cardiac status such as Unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry and ejection fraction less than 40
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV.
- Severe hypertension (diastolic BP > 100 on medication or persistently elevated SBP>140 mmHg despite adequate antihypertensive medications)
- History of immunocompromise including those who are HIV positive.
- History of intracranial hemorrhage, traumatic brain injury or thalamic stroke.
- Cerebrovascular disease (multiple CVA or CVA within 6 months)
- Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc.
- Subjects with a history of seizures within the past year
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)
- Are participating or have participated in another clinical trial in the last 30 days
- Skull Density Ratio (SDR) less than 0.4 ± 0.05
- History of multiple sclerosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Thalamotomy of Central Lateral Thalamic Nucleus for the Treatment of Medication-refractory Trigeminal Neuralgia
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.
Read the detailed description
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.
Usually, people with trigeminal pain receive medicines to control the pain. However, these medications may not give adequate pain relief. They may have unwanted side effects. In many patients with Trigeminal Neuralgia, a blood vessel compressing the nerve could be responsible for this condition. In such patients, surgery (also called micro-vascular decompression) is considered to be the best option if the medications do not control the pain. However, not all patients are good candidates for surgical correction and some patients may have recurrence of pain following surgical correction.
When surgery is not possible or recommended, other procedures are also available to patients. Such procedures usually result in selective damage to the nerve pain fibers in the Trigeminal nerve. Examples of these treatments include injection of materials such as Glycerol into the nerve, compression of the nerve with a balloon or selective radiation treatment of the nerve (stereotactic Radiosurgery). These treatments may not always improve the patient's pain or may only relieve the pain for a short duration of time.
These treatments may also result in damage to the nerve fibers that carry sensation from the face.
Our study will assess a new device for treating patients who have disabling pain that has not responded to medications or medications along with surgery. The device we will assess is called the ExAblate Transcranial focused ultrasound system. In this study, we will use this device to send ultrasound waves through the skull to precisely target and treat a tiny area of the brain called central lateral nucleus.
- Conditions
- Trigeminal Neuralgia
- Being tested
- ExAblate Transcranial treatment
- Keywords
- Trigeminal pain, MR guided focused ultrasound
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate Transcranial treatmentDevice
Also called The ExAblate® MR guided focused ultrasound system
Patients' head will be placed in ExAblate device to hold it still for the treatment. The ExAblate Transcranial helmet will be placed on their head. The investigators will measure the study participant's heart, blood pressure, temperature, and breathing rate before the treatment begins. MRI scans will be taken to make sure the ultrasound waves will be aimed exactly within the target. A series of MR images will be taken to identify the target area, and plan the study treatment. The study investigators will decide on the area of participant's brain that will be treated. The ExAblate Transcranial system will compute a plan to cover the treatment area. This area is gradually heated while monitoring the patient's responses and neurologic examination.
| Study group | Role | What they receive |
|---|---|---|
| ExAblate Transcranial treatment | Experimental | The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain called central lateral thalamic nucleus. Ultrasound passes through the skin and skull and into the brain to focus on this particular spot. Receives: Device: ExAblate Transcranial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment related adverse events
Procedure related or device related adverse events will be reported, from the treatment day through the 6-month follow-up period.
Measured: All events will be reported up to 6 months from treatment
Secondary outcomes (4)
Change in pain intensity
Efficacy of ExAblate TcMRgFUS for Thalamotomy will be evaluated using Barrow Neurological Institute (BNI) pain intensity score.
Measured: 6 months
Change in pain intensity
Efficacy of ExAblate TcMRgFUS for Thalamotomy will be evaluated using Brief Pain Inventory-Facial.
Measured: 6 months
Change in pain intensity
Efficacy of ExAblate TcMRgFUS for Thalamotomy will be evaluated using Pain Numeric rating scale (NRS).
Measured: 6 months
Change in patient's perception of the effect of the procedure
Patient Global impression of change (PGIC): The effect of the procedure on patient perceived impact of pain related symptoms, emotions and quality of life will be measured using PGIC scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start16 Aug 2021
- Primary completion28 May 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation, InSightec
- Responsible party
- Principal investigator, Dheeraj Gandhi, University of Maryland, Baltimore
- Investigators
- Dheeraj Gandhi, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579692
- Sponsor's protocol ID
- HP-00092927
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2020
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Thalamotomy of Central Lateral Thalamic Nucleus for the Treatment of Medication-refractory Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT04579692
- Acronym / sponsor ID
- HP-00092927
- Conditions
- Trigeminal Neuralgia
- Keywords
- Trigeminal pain, MR guided focused ultrasound
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation, InSightec
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.
Detailed description
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.
Usually, people with trigeminal pain receive medicines to control the pain. However, these medications may not give adequate pain relief. They may have unwanted side effects. In many patients with Trigeminal Neuralgia, a blood vessel compressing the nerve could be responsible for this condition. In such patients, surgery (also called micro-vascular decompression) is considered to be the best option if the medications do not control the pain. However, not all patients are good candidates for surgical correction and some patients may have recurrence of pain following surgical correction.
When surgery is not possible or recommended, other procedures are also available to patients. Such procedures usually result in selective damage to the nerve pain fibers in the Trigeminal nerve. Examples of these treatments include injection of materials such as Glycerol into the nerve, compression of the nerve with a balloon or selective radiation treatment of the nerve (stereotactic Radiosurgery). These treatments may not always improve the patient's pain or may only relieve the pain for a short duration of time.
These treatments may also result in damage to the nerve fibers that carry sensation from the face.
Our study will assess a new device for treating patients who have disabling pain that has not responded to medications or medications along with surgery. The device we will assess is called the ExAblate Transcranial focused ultrasound system. In this study, we will use this device to send ultrasound waves through the skull to precisely target and treat a tiny area of the brain called central lateral nucleus.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate Transcranial treatment | Experimental | Device: ExAblate Transcranial treatmentThe ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain called central lateral thalamic nucleus. Ultrasound passes through the skin and skull and into the brain to focus on this particular spot. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical Diagnosis of Classical or Idiopathic TN refractory to medical therapy
- Age greater than 21 and less than 75 years
- Subjects who are able and willing to give consent and able to attend all study visits
- Documented chronic, severe pain for more than 6 months duration
- Failure to respond to the usual therapeutic regimen considered to be standard of care for Trigeminal Neuralgia. The patient should have failed a trial of at least two classes of therapeutic agents, including an anticonvulsant agent
Key exclusion criteria (20 listed)
- Patient with contra-indications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblate Transcranial treatmentAlso: The ExAblate® MR guided focused ultrasound systemPatients' head will be placed in ExAblate device to hold it still for the treatment. The ExAblate Transcranial helmet will be placed on their head. The investigators will measure the study participant's heart, blood pressure, temperature, and breathing rate before the treatment begins. MRI scans will be taken to make sure the ultrasound waves will be aimed exactly within the target. A series of MR images will be taken to identify the target area, and plan the study treatment. The study investigators will decide on the area of participant's brain that will be treated. The ExAblate Transcranial system will compute a plan to cover the treatment area. This area is gradually heated while monitoring the patient's responses and neurologic examination. | Device | ExAblate Transcranial treatment |
Primary outcome
Incidence of Treatment related adverse events
Time frame: All events will be reported up to 6 months from treatment
Procedure related or device related adverse events will be reported, from the treatment day through the 6-month follow-up period.
4 secondary outcomes
Change in pain intensity
Time frame: 6 months
Change in pain intensity
Time frame: 6 months
Change in pain intensity
Time frame: 6 months
Change in patient's perception of the effect of the procedure
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dheeraj Gandhi, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate Transcranial treatment in people with Trigeminal Neuralgia, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment related adverse events (time frame: All events will be reported up to 6 months from treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.